BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21501383 · Received March 2, 2025

    Report

    Report Number
    2916596-2025-01221
    Event Type
    Injury
    Date Received
    March 2, 2025
    Date of Event
    June 1, 2023
    Report Date
    April 21, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS: 01JUN2023 AS PATIENTS WERE IMPLANTED FROM MAR2015 TO JUN2023. DEPARTMENT OF CARDIAC, THORACIC, VASCULAR SCIENCES AND PUBLIC HEALTH, UNIVERSITY OF PADOVA, PADUA, ITALY, DEPARTMENT OF CLINICAL ELECTROPHYSIOLOGY & CARDIAC PACING, CENTRO CARDIOLOGICO MONZINO, IRCCS, MILAN, ITALY, DEPARTMENT OF SYSTEMS MEDICINE, UNIVERSITY OF ROME TOR VERGATA, ROME, ITALY, CARDIOLOGY UNIT, LUIGI SACCO UNIVERSITY HOSPITAL, MILAN, ITALY, CARDIOLOGY UNIT, IRCCS, DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC AND SPECIALTY MEDICINE, SANT'ORSOLA HOSPITAL, UNIVERSITY OF BOLOGNA, BOLOGNA, ITALY, ARRHYTHMOLOGY AND ELECTROPHYSIOLOGY UNIT, SAN RAFFAELE HOSPITAL, IRCCS, MILAN, ITALY,CARDIOLOGY UNIT, UNIVERSITY MEDICAL CENTRE MANNHEIM, MANNHEIM, GERMANY, DEPARTMENT OF CARDIOLOGY AND ANGIOLOGY, FACULTY OF MEDICINE, HEART, CENTER FREIBURG UNIVERSITY, UNIVERSITY OF FREIBURG, GERMANY,CARDIOLOGY UNIT, FONDAZIONE IRCCS SAN GERARDO DEI TINTORI, MONZA, ITALY, DEPARTMENT OF RHYTHMOLOGY, UNIVERSITY HEART CENTER LUBECK, LUBECK, GERMANY, DEPARTMENT OF BIOMEDICAL SURGICAL AND DENTAL SCIENCES, UNIVERSITY OF MILAN, MILAN, ITALY, MONTEFIORE-EINSTEIN CENTER FOR HEART AND VASCULAR CARE, MONTEFIORE MEDICAL CENTER, ALBERT EINSTEIN COLLEGE OF MEDICINE AT MONTEFIORE HEALTH SYSTEM, BRONX, NY, USA, DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, BALTIMORE, USA MIGLIORE, F., SCHIAVONE, M., PITTORRU, R., FORLEO, G. B., DE LAZZARI, M., MITACCHIONE, G., BIFFI, M., GULLETTA, S., KUSCHYK, J., DALL¿AGLIO, P. B., ROVARIS, G., TILZ, R., MASTRO, F. R., ILICETO, S., TONDO, C., DI BIASE, L., GASPERETTI, A., TARZIA, V., & GEROSA, G. (2024). LEFT VENTRICULAR ASSIST DEVICE IN THE PRESENCE OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: DATA FROM A MULTICENTER EXPERIENCE. INTERNATIONAL JOURNAL OF CARDIOLOGY, 400, 131807. HTTPS://DOI.ORG/10.1016/J.IJCARD.2024.131807 THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF (B)(6)). NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B2: OUTCOMES ATTRIBUTED TO ADVERSE CORRECTED. SECTION B3: DATE OF EVENT CORRECTED. DATE OF EVENT HAS BEEN ENTERED AS 01JUN2023 AS PATIENTS WERE IMPLANTED FROM MAR2015 TO JUN2023. SECTION E: REPORTER INFORMATION CORRECTED. SECTION G2: REPORT SOURCE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO DEVICES WERE RETURNED FOR THIS EVALUATION. THE DEVICE SERIAL NUMBERS WERE NOT REPORTED AND WERE UNABLE TO BE DETERMINED DURING THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS CARDIAC ARRHYTHMIA AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE ARTICLE TITLED¿LEFT VENTRICULAR ASSIST DEVICE IN THE PRESENCE OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: DATA FROM A MULTICENTER EXPERIENCE¿ THAT THE HEARTMATE 3 MAY BE ASSOCIATED WITH CARDIAC ARRHYTHMIAS, ELECTROMAGNETIC INTERFERENCE (EMI), KIDNEY DISEASE, HEART TRANSPLANT (HT), AND DEATH. THIS WAS A MULTICENTER RETROSPECTIVE COHORT STUDY AMONG PATIENTS WITH A PREEXISTING S-ICD WHO UNDERWENT LVAD IMPLANTATION FOR ADVANCED HF DESPITE OPTIMAL MEDICAL THERAPY FROM MARCH 2015 AND JUNE 2023. THE STUDY POPULATION INCLUDED 30 PATIENTS (N = 25 MALES, 83.3%; MEDIAN AGE: 45 [38¿52] YEARS). THE MEDIAN TIME FROM S-ICD IMPLANTATION TO LVAD DEVICE IMPLANTATION WAS 12 [6¿25] MONTHS. BASELINE CLINICAL CHARACTERISTICS OF THE STUDY POPULATION ARE REPORTED IN TABLE 1. SEVEN (23%) PATIENTS RECEIVED AN S-ICD FOR SECONDARY PREVENTION. MOST PATIENTS HAD NON-ISCHEMIC CARDIOMYOPATHY (N = 23; 76.7%) WITH A MEDIAN LEFT VENTRICULAR (LV) EJECTION FRACTION OF 15 [15¿22]. INDICATIONS FOR LVAD IMPLANTATION WERE BRIDGE TO HT (N = 15; 50%), BRIDGE TO HT CANDIDACY (N = 13; 43%) AND DESTINATION THERAPY (N = 2; 7%). IMPLANTED LVAD MODELS WERE HEARTMATE III (N =19; 63%), HEARTWARE (N =5; 17%), JARVIK 2000 (N =5; 17%) AND LEVITRONIX, PARACORPOREAL LVAD (N =1; 3%). FROM THE BASELINE PATIENT CHARACTERISTICS PROVIDED. 7 OF THE 30 PATIENTS HAD KIDNEY DISEASE, AND 2 HAD ATRIAL FIBRILLATION (AF). THE ONSET WAS NOT SPECIFIED AS BEING PRE-LVAD IMPLANTATION. EMI OVERSENSING IN AT LEAST 1 SENSING VECTOR OCCURRED IN 21 (70%) PATIENTS: 14 OF 19 (73%) WITH THE HEARTMATE III, 4 OF 5 (80%) WITH THE JARVIK 2000, 3 OF 5 (60%) WITH THE HEARTWARE (SEE FIG. 1). SIX PATIENTS (20%) EXPERIENCED A TOTAL OF 95 INAPPROPRIATE SHOCKS (IS) DUE TO EMI. SIX PATIENTS (20%) EXPERIENCED A TOTAL OF 14 APPROPRIATE SHOCKS FOR VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF). NO COMPLICATIONS OCCURRED. NO S-ICD EXTRACTION BECAUSE OF NEED FOR ATP, INEFFECTIVE THERAPY, OR INFECTION WAS REPORTED. DURING FOLLOW-UP, 5 PATIENTS (16%) UNDERWENT HT AND 7 PATIENTS (23%) DIED BECAUSE OF CARDIAC DEATH DUE TO WORSENING HF. HEARTMATE 3 AND HEARTWARE HVAD OPERATE AT A LOWER ROTATIONAL SPEED, GENERATING LOW FREQUENCY EMI (30¿150 HZ) THAT IS LESS LIKELY TO BE REMOVED BY DEVICE FILTERS RESULTING IN EMI OVERSENSING AND INAPPROPRIATE THERAPY [11]. IN CONCLUSION, CONCOMITANT USE OF LVADS AND S-ICDS WAS FEASIBLE IN MOST PATIENTS. HOWEVER, THE POTENTIAL RISK OF EMI OVERSENSING, IS, AND UNDER SENSING IN THE POST-OPERATIVE PERIOD FOLLOWING LVAD IMPLANTATION SHOULD BE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146761 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O